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Completed

NCT Number: NCT04042740

Glecaprevir/Pibrentasvir Fixed-dose Combination Treatment for Acute Hepatitis C Virus Infection

The purpose of this study was to assess the efficacy of a fixed dose combination (FDC) of glecaprevir/pibrentasvir (G/P) given for 4 weeks for treatment of acute hepatitis C (HCV), with or without HIV-1 coinfection.

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Key information

Conditions

Hepatitis C Infection Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Genital Diseases HIV Infection HIV Infections Hepatitis Hepatitis C Hepatitis, Viral, Human Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Liver Diseases RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Instituto de Pesquisa Clinica Evandro Chagas (12101), Rio de Janeiro, Brazil

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About this study

The study was conducted in two steps. In Step 1, participants received four weeks of treatment with G/P for acute HCV infection and were then followed 24 weeks post treatment. Participants with HCV recurrence (reinfection, suspected relapse or undefined post-treatment viremia) or HCV virologic failure before or at the Step 1 Week 16 entered Step 2 and were offered HCV re-treatment. The remaining participants were followed in Step 1 for a total of 28 weeks. The study primary and secondary outcome measures pertain to Step 1.

In Step 2, participants were re-treated for up to 16 weeks (G/P or alternate regimen through standard of care), and were followed for 24 weeks post treatment. This post-treatment follow-up included a visit for the determination of HCV sustained virologic response (SVR12) after re-treatment. All summaries of data captured from Step 2 are pooled across HCV re-treatment regimens, as specified in the Statistical Analysis Plan.

In Step 1, study visits were scheduled at study entry, weeks 1 and 2 (on-treatment), week 4 (treatment discontinuation), and weeks 8, 12, 16 and 28 (post-treatment follow-up). In Step 2, participants had study visits during the re-treatment period, where the number of visits depended on the re-treatment regimen, and at weeks 12 and 24 post treatment. Study visits included physical examinations, clinical assessments, blood and urine collection, questionnaires, and HCV re-infection prevention counseling.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Acute HCV infection (or reinfection) within 24 weeks prior to entry
  • Detectable HCV RNA at the screening visit

Exclusion criteria

  • Any HCV treatment during the current acute HCV infection episode
  • Known preexisting cirrhosis
  • Acute HIV-1 infection
  • Presence of active or acute AIDS-defining opportunistic infections, active serious infection (other than HIV-1 or HCV), active hepatitis B virus (HBV) or active hepatitis A virus (HAV)
  • Chronic use of systemically administered immunosuppressive agents
  • History of solid organ transplantation
  • History of conditions that could interfere with the absorption of the study drug
  • Concurrent use of prohibited medications
  • Known hypersensitivity to glecaprevir or pibrentasvir, the metabolites, or parts of the formulation
  • Females who are pregnant or breastfeeding
  • Males with pregnant female partner

Treatment and study plan

Glecaprevir/Pibrentasvir (G/P)

Drug

Fixed-dose combination (FDC) tablets containing 100 mg of glecaprevir and 40 mg of pibrentasvir; administered as 3 tablets orally.

Other names: Mavyret

Primary outcomes

  1. Percentage of Participants With Sustained Virologic Response at 12 Weeks Post Treatment Discontinuation (SVR12)

    Time frame: Week 16 (12 weeks post study treatment)

    SVR12 defined as unquantifiable HCV RNA (less than the lower limit of quantification [LLOQ], target detected [TD] or target not detected [TND]) at study visit 12 weeks post treatment (Week 16). If a participant did not have HCV RNA measurement at Week 16, the participant was considered as SVR12 failure, unless there were preceding and subsequent HCV RNA measurements that were both LLOQ (either TD or TND).

  2. Percentage of Participants Who Experienced Adverse Events (AEs)

    Time frame: From study entry to Week 8 (4 weeks post study treatment)

    Study protocol required reporting of (1) AEs Grade greater than or equal to 2, (2) AEs that led to a change in study treatment regardless of grade and (3) AEs meeting ICH definition of serious AE (SAE) or Expedited AE (EAE) reporting requirement. DAIDS AE Grading Table (V2.1) and DAIDS EAE Manual (V2.0) were used.

  3. Number of Participants Who Completed 4 Weeks of Treatment Without Discontinuation Due to AEs

    Time frame: From study entry to Week 4

    Number of participants who completed 4 weeks of treatment without discontinuation due to AEs

Secondary outcomes

  1. Percentage of Participants With HCV RNA Less Than LLOQ

    Time frame: Weeks 1, 2, 4, 8, 12, 28

    Percentage of participants with HCV RNA less than LLOQ (TD or TND). Given the substantial amount of missing data due to the SARS-CoV-2 pandemic, the planned analysis of 90% confidence intervals for the percentage of participants with HCV RNA <LLOQ at study visits could not be conducted in a meaningful way.

  2. Number of Participants With HCV Virologic Failure

    Time frame: From Week 1 to Week 16

    Virologic failure defined as failure to achieve unquantifiable HCV RNA or confirmed increase in HCV RNA greater than 1 log10 from on-treatment nadir

Other outcomes

  1. Number of Participants by HCV Re-Treatment Regimen in Step 2

    Time frame: At Step 2 entry (median time of Step 2 entry was at 21 weeks after study entry.

    Participants who experienced HCV re-infection, suspected relapse, virologic failure, or undefined post-treatment viremia in Step 1 were offered to enter Step 2 for re-treatment. HCV re-treatment regimens may have included various regimens including study-provided G/P and alternate regimens through clinical care. This outcome measure is used to report the re-treatment regimens observed in Step 2.

Sponsors and collaborators

Lead sponsor

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

Network

Collaborators

  • AbbVie
  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study title

Glecaprevir/Pibrentasvir Fixed-dose Combination Treatment for Acute Hepatitis C Virus Infection (PURGE-C)

Acronym: PURGE-C

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Aug 2, 2019
Registry last updated
Jul 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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